Company ยท US
Abbott Molecular, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2025. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
47recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | 10 |
| OOI | Real Time Nucleic Acid Amplification System | 9 |
| MZP | Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus | 7 |
| JJH | Clinical Sample Concentrator | 5 |
| MKT | Hepatitis Viral B Dna Detection | 3 |
| MVU | Reagents, Specific, Analyte | 3 |
| QEP | Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections | 3 |
| KEO | Formulations, Paraffin, All | 2 |
| LSK | Dna-Reagents, Chlamydia | 2 |
| OVQ | Chronic Lymphocytic Leukemia Fish Probe Kit | 2 |
| QLX | Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna | 2 |
| JQW | Station, Pipetting And Diluting, For Clinical Use | 1 |
| KEY | Stainer, Tissue, Automated | 1 |
| KPA | Slide Stainer, Automated | 1 |
| LSL | Dna-Reagents, Neisseria | 1 |
| MAO | Dna-Probe, Human Chromosome | 1 |
| MAQ | Kit, Dna Detection, Human Papillomavirus | 1 |
| MKZ | Dna Probe, Nucleic Acid Amplification, Chlamydia | 1 |
| MTL | Monitor,Test,Hiv-1 | 1 |
| OWK | Early Growth Response 1 (Egr) Fish Probe Kit | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 25, 2025 | K252102 | Alinity m HCV Abbott Molecular, Inc. | MZP |
| Jul 28, 2025 | K243489 | Alinity m EBV (09N43-095) Abbott Molecular, Inc. | QLX |
| Jul 1, 2025 | K243485 | Alinity m CMV Abbott Molecular, Inc. | PAB |
| Mar 24, 2025 | K241921 | Alinity m BKV Abbott Molecular, Inc. | QMI |
| Feb 14, 2025 | K241573 | Alinity m Resp-4-Plex Abbott Molecular, Inc. | QOF |
| Jan 30, 2025 | K243410 | simpli-COLLECT STI Test Abbott Molecular | QYA |
| Dec 6, 2024 | K241580 | Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086) Abbott Molecular | QQX |
| May 3, 2024 | K233349 | Alinity m HSV 1 & 2 / VZV Abbott Molecular, Inc. | PGI |
| Mar 3, 2023 | K222379 | Alinity m STI Assay Abbott Molecular, Inc. | QEP |
| Jul 15, 2022 | K212778 | Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. Abbott Molecular, Inc. | QLX |
| Apr 29, 2022 | K202977 | Alinity m STI Assay Abbott Molecular, Inc. | QEP |
| May 9, 2014 | K140354 | ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG Abbott Molecular, Inc. | LSL |
| Sep 13, 2013 | K131508 | VYSIS D7S486/CEP 7 FISH PROBE KIT Abbott Molecular, Inc. | PFG |
| Jul 29, 2013 | DEN130010 | VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION) Abbott Molecular, Inc. | PDO |
| Aug 29, 2011 | K091960 | VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020 Abbott Molecular, Inc. | OWK |
| Aug 9, 2011 | K100015 | VYSIS CLL FISH PROBE KIT (VYSIS LSI TP53 SPECTRUMORANGE/ATM SPECTRUMGREEN) AND LSI D135319 SPECTRUMORANGE/13Q34 Abbott Molecular, Inc. | OVQ |
| May 28, 2010 | K092705 | ABBOTT M2000SP AND ABBOTT M2000RT, MODELS 9K14-01 (G-SERIES), 9K14-02 (E-SERIES), 9K1501 Abbott Molecular, Inc. | OOI |
| May 28, 2010 | K092704 | ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03 Abbott Molecular, Inc. | LSK |
| Jul 10, 2008 | K080739 | ABBOTT REALTIME CT/NG ASSAY AND MULTI-COLLECT SPECIMEN COLLECTION KIT Abbott Molecular, Inc. | MKZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2025 | Abbott Molecular, Inc. Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and diff Open, Classified |
QJR | None listed |
| May 12, 2025 | Abbott Molecular, Inc. Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection Open, Classified |
QJR | None listed |
| Apr 24, 2025 | Abbott Molecular, Inc. The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished). Open, Classified |
OOI | None listed |
| Oct 29, 2024 | Abbott Molecular, Inc. Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091; Open, Classified |
QEP | K222379 |
| Oct 29, 2024 | Abbott Molecular, Inc. Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091 Open, Classified |
MAQ | None listed |
| Apr 19, 2024 | Abbott Molecular, Inc. Alinity m System, Part Number: 08N53-002 Open, Classified |
OOI | None listed |
| Feb 26, 2024 | Abbott Molecular, Inc. Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.) Open, Classified |
OOI | None listed |
| Feb 26, 2024 | Abbott Molecular, Inc. In-vitro diagnostic kits:
(1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020;
(2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020;
(3) Abbott Vysis TelVysion 1p SpectrumGree Open, Classified |
MVU | None listed |
| Feb 26, 2024 | Abbott Molecular, Inc. In-vitro diagnostic kits:
(1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010;
(2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020; Open, Classified |
OYU | None listed |
| Nov 29, 2023 | Abbott Molecular, Inc. Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automa Open, Classified |
MZP | None listed |
| Apr 6, 2023 | Abbott Molecular, Inc. Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. Open, Classified |
OOI | None listed |
| Jan 20, 2023 | Abbott Molecular, Inc. Alinity m System.
The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction. Open, Classified |
OOI | None listed |
| Dec 20, 2022 | Abbott Molecular, Inc. Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 Open, Classified |
QJR | None listed |
| Dec 20, 2022 | Abbott Molecular, Inc. Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 Open, Classified |
QJR | None listed |
| Nov 18, 2022 | Abbott Molecular, Inc. Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use Open, Classified |
OOI | None listed |
| Aug 19, 2022 | Abbott Molecular, Inc. Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use. Open, Classified |
QJR | None listed |
| Jul 19, 2022 | Abbott Molecular, Inc. The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use. Completed |
MZP | None listed |
| Apr 6, 2022 | Abbott Molecular, Inc. Alinity m HBV AMP Kit (US and CE) Open, Classified |
MKT | None listed |
| Apr 6, 2022 | Abbott Molecular, Inc. Alinity m HBV Application Specification File (US and CE) Open, Classified |
MKT | None listed |
| Feb 11, 2022 | Abbott Molecular, Inc. Alinity m Integrated Reaction Units (IRU) Terminated |
OOI | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Terminated |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Terminated |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Open, Classified |
MZP | None listed |
| Dec 6, 2021 | Abbott Molecular, Inc. Alinity m System, Part No. 08N53-002 Open, Classified |
MZP | None listed |
| Oct 14, 2021 | Abbott Molecular, Inc. Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic Terminated |
QJR | None listed |
| Oct 14, 2021 | Abbott Molecular, Inc. Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic Terminated |
QJR | None listed |
| Oct 14, 2021 | Abbott Molecular, Inc. Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic Terminated |
QJR | None listed |
| Oct 14, 2021 | Abbott Molecular, Inc. Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic Terminated |
QJR | None listed |
| Oct 14, 2021 | Abbott Molecular, Inc. Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic Terminated |
QJR | None listed |
| Aug 4, 2021 | Abbott Molecular, Inc. Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13q34, SpectrumAqua/CEP 12 SpectrumGreen Probes Terminated |
OVQ | None listed |
| Jan 9, 2015 | Abbott Molecular The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | K092705 |
| Nov 25, 2014 | Abbott Molecular Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing. Terminated |
JJH | K092705 |
| Aug 8, 2014 | Abbott Molecular 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by pol Terminated |
JJH | K092705 |
| Apr 23, 2014 | Abbott Molecular The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 spectrum green probe and a Certificate of Analysis (COA). Chrom Terminated |
MVU | None listed |
| Jan 3, 2013 | Abbott Molecular Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; a Terminated |
JJH | K092705 |
| Jul 14, 2012 | Abbott Molecular Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 6 Terminated |
JQW | K092705 |
| Jan 11, 2012 | Abbott Molecular Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 Terminated |
JJH | K092705 |
| Oct 14, 2011 | Abbott Molecular Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des P Terminated |
OOI | K092705 |
| Feb 23, 2011 | Abbott Molecular Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
The Abbott RealTime HBV is an in vitro polymerase chain reaction (PCR) assay for the quantit Terminated |
MKT | None listed |
| Feb 23, 2011 | Abbott Molecular Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
The Abbott RealTime HIV-1 assay is an in vitro reverse transcription-polymerase chain reac Terminated |
MTL | None listed |
| Feb 23, 2011 | Abbott Molecular Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA
The Abbott RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for t Terminated |
LSK | K092704 |
| Aug 31, 2010 | Abbott Molecular VP 2000 Processor Heated Reagent Basins; automated slide stainer; Abbott Molecular Inc., Des Plaines, IL 60018; The basins are sold under the the following part numbers:
a) list 02J11-013, part number Terminated |
KPA | None listed |
| Mar 16, 2010 | Abbott Molecular Paraffin Pretreatment Reagent Kit III; each kit contains the following:
5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN),
5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Terminated |
KEO | None listed |
| Mar 16, 2010 | Abbott Molecular Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (P Terminated |
KEO | None listed |
| Aug 30, 2009 | Abbott Molecular VP 2000 Processor; an automated tissue stainer
100 volt - part 30-144100 or list 2J11-60;
117 volt - part 30-144101 or list 2J11-01, and part 30-102832 - processor only;
230 volt - part 30-144102 or l Terminated |
KEY | None listed |
| Mar 13, 2007 | Abbott Molecular Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list Terminated |
MVU | None listed |
| Jan 24, 2006 | Abbott Molecular Vysis LSI p16 (9p21)/CEP 9 (9p11-q11) Dual Color Probe Set; a locus specific identifier DNA probe consisting of a mixture of the LSI p16 probe labeled with a SpectrumOrange and the CEP 9 probe labeled Terminated |
MAO | None listed |